MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-05-31 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[76243904]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data supplied. The customer's quality control (qc) was in range at the time of the event. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse realigned all probes to the center of cuvette. The cse checked probe height alignments and realigned sample probe and sample dilution probe. The cse verified mixer alignments were within specifications. The cse verified dilution washer and reaction tray washer were within specification. The cse washed reaction tray washer with probe wash. The cse cleaned all probes and mixer rods. The customer performed a precision test and ran qc, resulting within range and specification. No further issues were found. The cause of the discordant, falsely depressed c-reactive protein result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[76243905]
A discordant, falsely depressed c-reactive protein result was obtained on a patient sample on an advia 1800 instrument. The initial result was released to the physician(s), which was questioned. The customer repeated the same sample on the same advia 1800 instrument, resulting higher. The customer issued a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed c-reactive protein result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00344 |
| MDR Report Key | 6600186 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-04-23 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-05-31 |
| Model Number | ADVIA 1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-31 |
| Model Number | ADVIA 1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |